BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE SECTOR II 54MM

    MDR report key: 3254820 · Received July 24, 2013

    Report

    Report Number
    MW5031105
    Event Type
    Injury
    Date Received
    July 24, 2013
    Date of Event
    August 9, 2006
    Report Date
    July 18, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2006, I UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY. I RECEIVED A DEPUY HIP SYSTEM CONSISTING OF A PINNACLE SECTOR II 54MM CUP WITH A 54 X 36 METAL-ON-METAL LINER, S-ROM 20X15X165 STEM WITH A 36+12MM NEK AND 20 D LARGE SPOUT AND A 36 +6MM COBALT CHROMIUM HEAD. SOON AFTER THIS SURGERY, I BEGAN EXPERIENCING SEVERE PAIN AND DISCOMFORT. SINCE THE IMPLANTATION OF THE PINNACLE DEVICE, I EXPERIENCE SEVERE PAIN AND DISCOMFORT WHEN WALKING, STANDING, AND SITTING. I ALSO EXPERIENCE SEVERE PAIN AND DISCOMFORT AND INFLAMMATION IN MY RIGHT THIGH AND RIGHT HIP AREA. DATES OF USE: (B)(6) 2009 TO PRESENT. DIAGNOSIS: LEFT OSTEOARTHRITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346271 PINNACLE SECTOR II 54MM METAL ON METAL HIP IMPLANT KWA DEPUY ORTHOPAEDICS
    346272 METAL LINER METAL ON METAL HIP IMPLANT KWA DEPUY ORTHOPAEDICS, INC.
    346273 S-ROM STEM METAL ON METAL IMPLANT KWA DEPUY ORTHOPAEDICS
    346274 HEAD METAL ON METAL HIP IMPLANT KWA DEPUY ORTHOPAEDICS

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R| S